Prospective Registry for Patients With Chest Pain in Emer... | NCT05058300

Studies
Prospective Registry for Patients With Chest Pain in Emergency Department

NCT05058300

Sponsor

Jena University Hospital

Status

Unknown status

Last Update Posted

Nov 7, 2023Actual

Enrollment

3,000Estimated

Phase

Not provided

Conditions

Chest Pain

Interventions

CT Thorax

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 20, 2017Actual

Primary Completion Date

Mar 23, 2022Actual

Completion Date

Oct 11, 2024Estimated

First Submitted Date

Jul 17, 2017

First Submission Date that Met QC Criteria

Sep 17, 2021

First Posted Date

Sep 27, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 6, 2023

Last Update Posted Date

Nov 7, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ulf Teichgräber, Prof. Dr. med., Jena University HospitalPrincipal Investigator

Lead Sponsor

Jena University HospitalOTHER

Collaborators

Name	Class
Zentrum für Klinische Studien Jena	OTHER
GE Healthcare	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

monocentric, prospective registry collection of clinical data of all patients with chest pain in emergency department and follow-up after 30 days

Detailed Description

An unselected patient-population with chest pain entering through the emergency department participate in a diagnostic survey where a chest pain algorithm based mainly on risk scores (Grace, TIMI, Heart) verifying the diagnostic forecasting power (sensitivity, specificity, negative and positive predictive value) of biomarkers, risk scores and imaging methods for diagnosing of potential life-threatening disease.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

30 Days

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

3,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with Chest Pain		An unselected patient-population with chest pain in emergency department	Device: CT Thorax

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CT Thorax	Device	CT Thorax (GE Revolution with chest pain algorithm)	Patients with Chest Pain

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Diagnostic forecast of biomarkers, risk scores and computer tomography	Diagnostic forecast compared to the initial suspected diagnosis and discharge diagnosis	From admission to emergency unit discharge

Secondary Outcomes

Measure	Description	Time Frame
Sensitivity	Sensitivity in result of biomarkers, risk scores and imaging methods	During diagnostic procedure
Specificity	Specificity in result of biomarkers, risk scores and imaging methods

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age >18 years old chest pain written confirmation of participants or legal representative

Exclusion Criteria:

thorax trauma

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

An unselected patient-population with chest pain in emergency department

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Wilhelm Behringer, Prof.	Emergency Unit, University hospital Jena	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Emergency		Jena	Thuringia	07747	Germany

Condition Browse Module

MeSH Terms

ID	Term
D002637	Chest Pain

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided